BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 678043 · Received July 13, 2005

    Report

    Report Number
    1317056-2005-00034
    Event Type
    Malfunction
    Date Received
    July 13, 2005
    Date of Event
    April 20, 2005
    Report Date
    June 15, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTS THAT UPON OPENING THEIR CONVENIENCE KIT THEY FIND THAT MANY OF THE FLUID DELIVERY LINES ARE KINKED NEAR THE MANIFOLD, POTENTIALLY CAUSING BUBBLES IN THE LINES. THERE HAS BEEN NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP CONVENIENCE KIT DTL BOSTON SCIENTIFIC/NAMIC NA 1033152

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability